Physical Activity and Nutritional Education as School-based Interventions to Control Obesity in Children and Adolescents (PANE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paulo Henrique de Araujo Guerra, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00985972
First received: September 23, 2009
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The aim of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity and/or nutrition education developed in the school environment. This study is intended to assist in future assembly and development of effective school practices related to preventing and reducing levels of overweight in children and adolescents.

Updated data from the systematic review:

5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC, ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services Abstracts, Sociological Abstracts, SPORTDiscus)

1,228 were excluded as duplicates by Eppi Reviewer

4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7 by cross-references list)

211 full text papers reviewed by EPHPP and GRADE tools

140 studies with data extracted

Body Mass Index Results:

  1. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02 (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%)
  2. Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%)
  3. Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomized community trials - Project PANE (manuscript under review) - Combined Physical Activity and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%) / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)

Condition Intervention
OVERWEIGHT
OBESITY
Behavioral: Physical Activity and Nutrition Education

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Physical Activity and Nutritional Education as School-based Interventions to Control Overweight in Children and Adolescents: a Systematic Review (Project PANE)

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: Assessments results should at least monitor the execution time of the intervention studies, with a minimum of two assessments: pre-and post-intervention. This requirement depends directly on the studies to be extracted in the systematic search. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body Weight [ Time Frame: requirement for pre and post-intervention assessments ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: requirement for pre and post-intervention assessments ] [ Designated as safety issue: Yes ]
    Systolic and Diastolic blood pressure


Enrollment: 41634
Study Start Date: June 2009
Study Completion Date: September 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
Groups of school intervention that involves a combination of the physical activity and nutrition education in subjects 6 to 18 years of age
Behavioral: Physical Activity and Nutrition Education
School-based interventions involving Physical Activity or/and Nutrition Education.
Control
Groups included in the same school communities that serve as reference for individuals involved in intervention.
Behavioral: Physical Activity and Nutrition Education
School-based interventions involving Physical Activity or/and Nutrition Education.

Detailed Description:

The inordinate increase in the prevalence of overweight and obesity at the international level today is one of the targets of concern the department of public health, and gradually has been the focus of many studies and interventions which emphasize the need for more evidence to clear and effective its prevention and reduction. Obesity can affect the short or long term health of individuals, through problems such as left ventricular hypertrophy in young-adult and atherosclerosis, which is due to the formation of plaques of fat in the arterial wall and may lead to coronary artery disease , cerebrovascular disease and peripheral vascular disease.

The promotion of regular practice of physical activity through physical education school can be an effective way to prevent obesity among children, especially girls. There is an inverse relationship between physical activity and incidence of hypertension. The earlier the entrance to the practice of physical activities, there will be more effective in combating the increase in body mass index (BMI).

Nutrition Education is to extend the knowledge on nutrition and the ability to understand the practices and eating behavior, improving the relationship of the individual in the environment which is introduced, allowing the taking of decisions under the situation presented.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children and adolescents aged 6 to 18 years of age included in the school environment, regardless of their ethnicity, social condition and weight range.

Criteria

Inclusion Criteria:

  • Randomized clinical / community trials whose main objective is the focus on control and / or reduction of body weight of the participants, conducted by a program developed in the scholar environment that promotes the practice of physical activity and healthy eating through nutrition education.
  • Studies that include participants aged 6 to 18 years of age, regardless of the range of weight.
  • There is no restriction ethnic, social, gender, nutritional status and physical fitness.
  • There is no limitation of language for critical evaluation of studies.

Exclusion Criteria:

  • Studies making use of pharmacological agents
  • Studies with participants who suffer from diseases, or specific clinical conditions, except obesity
  • Studies not conducted in the school environment
  • The duplicated data will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985972

Locations
Brazil
Heart Institute, General Hospital of Faculty of Medicine of University of Sao Paulo (InCor HCFMUSP)
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Moacyr MR Nobre, PhD University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Principal Investigator: Paulo Henrique A Guerra, DSc University of São Paulo, Faculty of Medicine, Heart Institute (InCor), Clinical Epidemiology Unit
Principal Investigator: Jonas A Silveira, MSc Federal University of São Paulo, Department of Pediatrics
  More Information

Publications:
Responsible Party: Paulo Henrique de Araujo Guerra, DSc., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT00985972     History of Changes
Other Study ID Numbers: PANE0575-08
Study First Received: September 23, 2009
Last Updated: March 14, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
PHYSICAL ACTIVITY
SCHOOL
NUTRITION
EDUCATION
OVERWEIGHT

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014